Referenced Documents List = TIME SINK
Don’t waste your time on extensive referenced documents lists. Nobody cares!
I often see medical device companies include long, long lists of every DHF document in their documentation front matter. You are wasting your time!
The FDA doesn’t care about this. EU MDR doesn’t require this. Your quality department shouldn’t care about this.
What I’ve observed is that engineers who don’t understand what the FDA actually wants will fill the front matter with fluff just to bulk up the document volume, imagining this will score brownie points with quality and regulatory agencies. It reminds me of that kid in school who wrote with extra large print to meet the minimum two page requirement. Don’t be that kid!
In all my years working in the medical device industry, I’ve never heard of an audit finding that a list of referenced documents was insufficient. This is zero-value-added busy work, which does nothing to reduce your company’s regulatory risk exposure.
A referenced document list should only include the specific documents that are actually referred to within the document, which a reader may wish to consult. For example, if a risk management report refers to a dFMEA, that document should be contained within the Referenced Documents list.
If one really wants to generate an inordinate amount of painful busy work for the company, then go ahead and list each document’s revision within the referenced documents list. Then every time you revise a document, you’re also forced to revise every other document that references it. OUCH!
In fact, the proper way to handle this is through a DHF Index. A DHF Index should not only list all the documents that contribute to a device history file, but also track the current revision of each document. Thus, whenever a DHF document is referenced, it is safe to assume the current revision is always applicable. The exception to this is for activities which represent a snapshot in development, associated with a specific product release. For example, a verification report for a design revision should specify which version of a design specification was verified. But most DHF documents are living documents – they are updated throughout the life of the product, and the current version is always applicable, with older versions being obsoleted.
Don’t waste your company’s precious resources generating fluff for your documentation front matter. Let Cyclops Engineering focus your efforts on the doing the things that regulatory agencies truly care about.
Cyclops Engineering 